eTMS for PTSD

Overseen By Jessica Florig, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Certain medications

Disqualifiers: Claustrophobia, Pregnancy, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called eTMS (EEG-enhanced Transcranial Magnetic Stimulation) to determine its effectiveness for veterans and first responders diagnosed with PTSD (post-traumatic stress disorder). The researchers aim to gather information on how this treatment affects both the body and behavior. Participants will receive either real eTMS or a placebo (a fake version of the treatment) to assess any differences in outcomes. The trial seeks veterans or first responders experiencing PTSD symptoms. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants on certain medications. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that eTMS is safe for treating PTSD?

Research shows that eTMS (Electroencephalogram Transcranial Magnetic Stimulation) is generally safe. Past studies used eTMS to help veterans and first responders with PTSD (Post-Traumatic Stress Disorder), assessing treatment tolerance and side effects.

eTMS, a brain therapy, uses magnetic fields to stimulate brain cells. The FDA has approved this treatment for Major Depressive Disorder, indicating its safety has been studied.

So far, studies report that eTMS is well-tolerated, with no major side effects. This means participants did not experience severe or harmful reactions. However, individual experiences can vary, and ongoing research aims to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about eTMS for PTSD because it offers a new way to tackle the condition using electromagnetic fields. Unlike traditional treatments like therapy or medications such as SSRIs and SNRIs, eTMS uses transcranial magnetic stimulation to target brain areas associated with PTSD symptoms directly. This non-invasive approach is compelling because it could potentially offer faster relief with fewer side effects compared to conventional medications. Additionally, eTMS provides a more targeted treatment, which might lead to better outcomes for patients who haven't responded well to other options.

What evidence suggests that eTMS is effective for PTSD?

Research has shown that transcranial magnetic stimulation (TMS) can help treat PTSD by targeting specific brain areas related to stress and trauma. Studies have found that TMS, particularly when applied to the dorsolateral prefrontal cortex (DLPFC), effectively reduces PTSD symptoms. In this trial, participants may receive a newer method called eTMS, which uses EEG (a test that measures brain waves) to customize treatment for each person. Early results suggest that eTMS is safe and might enhance the effectiveness of traditional TMS in reducing PTSD symptoms for veterans and first responders. ^{1 2 3 5 6}

Who Is on the Research Team?

Wynn Legon, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

Are You a Good Fit for This Trial?

This trial is for veterans and first responders who have been diagnosed with PTSD. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Veteran or first responder diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

Exclusion Criteria

Claustrophobia

Pregnant

Unable to calculate EEG alpha frequency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Testing

Participants undergo 2 days of extensive testing including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study

1 week

2 visits (in-person)

Treatment

Participants receive either active or sham eTMS application

5 weeks

Post-Treatment Testing

Participants undergo 2 days of extensive testing after eTMS application, including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eTMS

Trial Overview The study tests eTMS, a personalized brain stimulation treatment, on individuals with PTSD. It's a double-blind trial meaning neither the participants nor the researchers know who gets real treatment or placebo. The effects are measured before and after treatment.

How Is the Trial Designed?

Group I: eTMS Experimental Treatment 1 Intervention

The active side of a TMS coil will be used to administer eTMS application.

Group II: eTMS sham Placebo Group 1 Intervention

The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.

eTMS is already approved in United States, European Union for the following indications:

Approved in United States as TMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraines
• Anxiety with depression
• Smoking dependence
• Bipolar depression
• Depression in adolescents 15 years and older

Approved in European Union as TMS for:

• Depression
• Obsessive-Compulsive Disorder (OCD)
• Migraines
• Anxiety disorders

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Wave Neuroscience

Industry Sponsor

Trials

14

Recruited

1,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) is a safe treatment option for depression and shows potential for alleviating symptoms of post-traumatic stress disorder (PTSD), particularly when applied to the right dorsolateral prefrontal cortex.

High-frequency rTMS appears to be more effective than low-frequency rTMS in treating PTSD symptoms, possibly by increasing levels of brain-derived neurotrophic factor, which supports brain health and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. Jensen, BS., Ashkanian, M.[2018]

In a study involving 24 PTSD patients, high-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz significantly improved core PTSD symptoms and alleviated anxiety over 10 daily sessions.

The results indicate that rTMS targeting the right dorsolateral prefrontal cortex is more effective than low-frequency or sham stimulation, suggesting its potential as a therapeutic intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. Cohen, H., Kaplan, Z., Kotler, M., et al.[2022]

In a study of 29 individuals with comorbid major depressive disorder (MDD) and posttraumatic stress disorder (PTSD), machine learning analysis of EEG coherence was able to predict clinical outcomes after TMS treatment, with a high area under the curve of 0.83 for MDD and 0.71 for PTSD.

The study demonstrated that EEG coherence could effectively differentiate between pre- and post-TMS treatment states, achieving an accuracy of around 75-78% across different brain wave frequencies, suggesting potential for EEG as a screening tool for TMS candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of machine learning in predicting clinical response to transcranial magnetic stimulation in comorbid posttraumatic stress disorder and major depression: A resting state electroencephalography study. Zandvakili, A., Philip, NS., Jones, SR., et al.[2021]

This pilot study involving 8 veterans with PTSD shows that combining repetitive transcranial magnetic stimulation (rTMS) with prolonged exposure (PE) therapy is safe and feasible, with a dropout rate similar to traditional PE therapy.

While the overall improvement in PTSD symptoms was not statistically significant, veterans with comorbid major depression experienced notable benefits from rTMS, suggesting potential for enhanced treatment outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. Fryml, LD., Pelic, CG., Acierno, R., et al.[2020]

Bilateral sequential theta-burst stimulation (bsTBS) was well tolerated in a small study of 8 military veterans with treatment-resistant depression (TRD) and comorbid PTSD, showing promising remission rates of 25% and response rates of 38% for depression scores.

The study suggests that bsTBS may be a viable therapeutic option for patients with TRD and PTSD, indicating the need for larger studies to further evaluate its efficacy compared to other rTMS treatment paradigms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. Vaithianathan, T., Blair, M., Soares, V., et al.[2022]

In a study involving 103 veterans with combat-related PTSD, those who received repetitive Transcranial Magnetic Stimulation (rTMS) before Cognitive Processing Therapy (CPT) experienced significantly greater reductions in PTSD symptoms compared to those who received sham rTMS.

The benefits of combining rTMS with CPT were not only evident during treatment but also sustained for up to six months after the therapy, indicating a lasting impact on symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. Kozel, FA., Motes, MA., Didehbani, N., et al.[2018]

In a study of 20 male combat veterans with treatment-resistant PTSD, repetitive transcranial magnetic stimulation (rTMS) significantly reduced hyperarousal symptoms, suggesting its potential effectiveness for this specific symptom.

However, rTMS did not show significant improvements in overall PTSD symptoms or co-occurring depression and anxiety scores, indicating that while it may help with hyperarousal, further research is needed to understand its broader efficacy in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? Oznur, T., Akarsu, S., Celik, C., et al.[2014]

A survey of 152 service members and veterans revealed that cranial electrotherapy stimulation (CES) led to clinical improvements of 25% or more in anxiety (66.7%), PTSD (62.5%), insomnia (65.3%), and depression (53.9%).

Participants overwhelmingly perceived CES as safe (99.0%), and those not on prescription medications found it more effective than when combined with medication, highlighting CES as a promising noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. Kirsch, DL., Price, LR., Nichols, F., et al.[2015]

In a study of 12 patients with both PTSD and major depression, 75% experienced a significant improvement in depression symptoms after receiving repetitive transcranial magnetic stimulation (rTMS) over 10 days.

While rTMS showed effectiveness in alleviating depression and related symptoms like anxiety and insomnia, it had only minimal impact on the core symptoms of PTSD, suggesting that different treatment approaches may be needed for mood and PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation treatment of comorbid posttraumatic stress disorder and major depression. Rosenberg, PB., Mehndiratta, RB., Mehndiratta, YP., et al.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06081309

NCT06081309 | EEG Personalized Transcranial Magnetic ... The primary outcome for the Study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06294106

eTMS for Veterans and First Responders With PTSD Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558793/

Transcranial magnetic stimulation for post-traumatic stress ... One-year clinical outcomes ... Review of the effectiveness of transcranial magnetic stimulation for post-traumatic stress disorder.

4. ctv.veeva.com ctv.veeva.com/study/eeg-personalized-transcranial-magnetic-stimulation-etms-for-post-traumatic-stress-disorder

EEG Personalized Transcranial Magnetic Stimulation (eTMS ... eTMS-PTSD-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. The Study is intended to evaluate ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Regardless of laterality, TMS application to the DLPFC seems to produce the most effective results in treatment of PTSD. Effectiveness of TMS therapy is ...

6. etmsfda.com etmsfda.com/

eTMS FDA | Brain Stimulation Therapy for PTSD & Brain Injuries The purpose of this study is to investigate whether eTMS improves symptoms associated with PTSD. TMS is FDA-cleared for use in Major Depressive Disorder.